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DOXYCYCLINE HYCLATE Recall D-1054-2022

Description: Doxycycline Hyclate Tablets, USP, 100 mg, 50-count carton (10 tablets each blister pack x 5), Rx only, MFG: Major Pharma, NDC 0904-0430-06

DOXYCYCLINE HYCLATE Recall D-1054-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1054-2022
Event ID89646
BrandDOXYCYCLINE
Generic NameDOXYCYCLINE HYCLATE
ManufacturerDOXYCYCLINE HYCLATE
Active SubstanceDOXYCYCLINE HYCLATE
Drug RouteORAL
DistributionUSA nationwide.
Quantity108 cartons/50 blisters per carton
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC0904-0430
Recall Initiation Date20220413
Report Date20220615
Classification Date20220609
Address9954 Maryland DriveDeep Run Iii Ste. 4000
Richmond, VA 23233
United States
Recalling FirmMckesson Medical-Surgical Inc. Corporate Office
Initial Notification Letter
Unique Ingredient Identifier19XTS3T51U
Drug Application NumberANDA065095
Structured Product Labeling (SPL ID)a43d088c-e5b1-4bff-ac7e-e4641f0dabba
Structured Product Labeling (SPL Set ID)e7c14a8e-c713-4f03-94e8-1ec9ae077d4d
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